A pre and post study of the effect and safety of Hominax to improve sperm health

Max Biocare Pty Ltd0 sites62 target enrollmentFebruary 15, 2016

Overview

No summary available.

Registry

who.int

Start Date

February 15, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

Male

Sponsor

•1\.Age 20 to 60 years;
•2\.Evidence of a personally signed informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
•3\.Normal rheologic characteristics (appearance, consistency, and liquefaction) of semen, and pH in the normal range;
•4\.Sperm concentration between \=\> 5 x 106/mL and at least ONE of the following within 3 months prior to screening visit:
•a.Sperm concentration \<\= 15 x 106/mL \[1, 2] OR
•b.Progressive motility (PR, %) \[1, 2] ) \<\= 32% OR
•c.Normal sperm morphology \<\= 4% \[1, 2] on two semen samples 7\-21 days apart within 3 months of enrollment into the study;
•5\.Seminal white blood cells \<1 x 106/mL;
•6\.Willing to cease all vitamin and complementary medicine supplements from screening and for the duration of participation in the study;
•7\.Fluent in spoken \& written English;

•1\.Non\-idiopathic infertility. That is, participants to be excluded if their infertility has a known cause such as, but not limited to: infectious genital diseases, anatomic abnormalities of the genital tract including clinical varicocele, anti\-spermatozoa antibodies, taking medication with known spermicidal effects;
•2\.Leucocytospermia (WBC \>1 x106 ml in seminal plasma);
•3\.Sperm concentration \< 5 x 106/mL in the semen sample used to confirm male factor infertility to exclude severe condition;
•4\.Smoking if greater than or equal to 1 pack per week (on average),
•a.Alcohol if greater than or equal to 20 grams alcohol (equivalent to 2 standard drinks, on average, per day) or
•b.Drug addiction to any substance, and occupational chemical exposure;
•5\.If diagnosed with a bleeding disorder; or hypothyroidism; or seizures; or HIV/AIDs; or hepatitis of any cause; or an autoimmune disease; or planning to have angioplasty during the study;
•6\.If taking thyroid hormone, or anti\-coagulant or anti\-platelet medication, or anti\-seizure medication, or HIV/AIDs medication; or barbiturates;
•7\.Has known allergies or hypersensitivities to the components of Hominax or capsule excipients.
•8\.Has a history of gastrointestinal condition and/or experiences adverse reactions to swallowing medications (e.g. vomiting, reflux etc.) and / or during digestion of medications after consumption (e.g. acute diarrhoea/constipation; abdominal cramps; occult blood etc.)